User interface for external charger for implantable medical device

ABSTRACT

User interface for external power source, recharger, for an implantable medical device. At least some of patient controls and display icons of an energy transfer unit are common with at least some of the patient controls and the display icons of a patient control unit. An energy transfer unit is operable by the patient with less than three operative controls to control energy transfer from the external energy transfer unit to the implantable medical device. An external antenna having a primary coil can inductively transfer energy to a secondary coil of the implantable medical device when the external antenna is externally placed in proximity of the secondary coil. An energy transfer unit has an external telemetry coil allowing the energy transfer unit to communicate with the implantable medical device through the internal telemetry coil in order to at least partially control the therapeutic output of the implantable medical device.

RELATED APPLICATIONS

This application is claims priority to U.S. Provisional Application Ser.No. 60/508,198, filed Oct. 2, 2003, entitled User Interface for ExternalCharger for Implantable Medical Device, and from U.S. ProvisionalApplication Ser. No. 60/513,732, filed Oct. 23, 2003, entitled UserInterface for External Charger for Implantable Medical Device. Theentire contents of both of the foregoing applications are herebyincorporated by reference.

FIELD OF THE INVENTION

This invention relates to implantable medical devices and, inparticular, to energy transfer devices, systems and methods forimplantable medical devices.

BACKGROUND OF THE INVENTION

Implantable medical devices for producing a therapeutic result in apatient are well known. Examples of such implantable medical devicesinclude implantable drug infusion pumps, implantable neurostimulators,implantable cardioverters, implantable cardiac pacemakers, implantabledefibrillators and cochlear implants. Of course, it is recognized thatother implantable medical devices are envisioned which utilize energydelivered or transferred from an external device.

A common element in all of these implantable medical devices is the needfor electrical power in the implanted medical device. The implantedmedical device requires electrical power to perform its therapeuticfunction whether it be driving an electrical infusion pump, providing anelectrical neurostimulation pulse or providing an electrical cardiacstimulation pulse. This electrical power is derived from a power source.

Typically, a power source for an implantable medical device can take oneof two forms. The first form utilizes an external power source thattranscutaneously delivers energy via wires or radio frequency energy.Having electrical wires which perforate the skin is disadvantageous due,in part, to the risk of infection. Further, continuously couplingpatients to an external power for therapy is, at least, a largeinconvenience. The second form utilizes single cell batteries as thesource of energy of the implantable medical device. This can beeffective for low power applications, such as pacing devices. However,such single cell batteries usually do not supply the lasting powerrequired to perform new therapies in newer implantable medical devices.In some cases, such as an implantable artificial heart, a single cellbattery might last the patient only a few hours. In other, less extremecases, a single cell unit might expel all or nearly all of its energy inless than a year. This is not desirable due to the need to explant andre-implant the implantable medical device or a portion of the device.One solution is for electrical power to be transcutaneously transferredthrough the use of inductive coupling. Such electrical power or energycan optionally be stored in a rechargeable battery. In this form, aninternal power source, such as a battery, can be used for directelectrical power to the implanted medical device. When the battery hasexpended, or nearly expended, its capacity, the battery can be rechargedtranscutaneously, via inductive coupling from an external power sourcetemporarily positioned on the surface of the skin.

Transcutaneous energy transfer through the use of inductive couplinginvolves the placement of two coils positioned in close proximity toeach other on opposite sides of the cutaneous boundary. The internalcoil, or secondary coil, is part of or otherwise electrically associatedwith the implanted medical device. The external coil, or primary coil,is associated with the external power source or external charger, orrecharger. The primary coil is driven with an alternating current. Acurrent is induced in the secondary coil through inductive coupling.This current can then be used to power the implanted medical device orto charge, or recharge, an internal power source, or a combination ofthe two.

Since it may be necessary for the patient to operate the external powersource and since the patient may not be medically skilled norelectronically skilled, it is desirable that the external power sourcehave a user interface that is both intuitive and simple to use andoperate.

SUMMARY OF THE INVENTION

In an embodiment, the present invention provides an implantable medicaldevice system. An implantable medical device provides a therapeuticoutput to a patient. An external patient control unit can be operativelycoupled via telemetry with the implantable medical device allowing thepatient to control the therapeutic output of the implantable medicaldevice. An external energy transfer unit can be operatively coupled tothe implantable medical device to transcutaneously transfer energy tothe implantable medical device. The external patient control unit has auser interface operable by the patient having patient controls anddisplay icons indicative of a status of operation of the patient controlunit. The energy transfer unit has a user interface operable by thepatient having patient controls and display icons indicative of a statusof operation of the energy transfer unit. At least some of the patientcontrols and the display icons of the energy transfer unit are commonwith at least some of the patient controls and the display icons of thepatient control unit.

In another embodiment, the present invention provides an external energytransfer unit adapted to transcutaneously transfer energy to animplantable medical device for providing a therapeutic output to apatient. The implantable medical device is capable of communication withan external patient control unit allowing the patient to control thetherapeutic output of the implantable medical device. The externalpatient control unit has a user interface operable by the patient havingpatient controls and display icons indicative of a status of operationof the patient control unit. A user interface operable by the patienthas patient controls and display icons indicative of a status ofoperation of the energy transfer unit. At least some of the patientcontrols and the display icons of the energy transfer unit are commonwith at least some of the patient controls and the display icons of thepatient control unit.

In another embodiment, the present invention provides a method ofproviding therapeutic output to a patient using an implantable medicaldevice. An external patient control unit is operatively coupled viatelemetry with the implantable medical device allowing the patient tocontrol the therapeutic output of the implantable medical device. Anexternal energy transfer unit is operatively coupled to the implantablemedical device to transcutaneously transfer energy to the implantablemedical device. The external patient control unit has a user interfaceoperable by the patient having patient controls and display iconsindicative of a status of operation of the patient control unit. Theenergy transfer unit has a user interface operable by the patient andhas patient controls and display icons indicative of a status ofoperation of the energy transfer unit. At least some of the patientcontrols and the display icons of the energy transfer unit are commonwith at least some of the patient controls and the display icons of thepatient control unit.

In a preferred embodiment, at least one of the display icons is an iconrepresentative of a state of charging of an energy storage device in theimplantable medical device.

In a preferred embodiment, at least one of the patient controls is acontrol for adjusting the therapeutic output of the implantable medicaldevice.

In a preferred embodiment, the external energy transfer unit inductivelycouples energy to the implantable medical device.

In a preferred embodiment, the implantable medical device has arechargeable energy storage device and wherein the energy transfer unitcharges the rechargeable energy storage device.

In another embodiment, the present invention provides an implantablemedical device system. An implantable medical device provides atherapeutic output to a patient. An external energy transfer unit can beoperatively coupled to transcutaneously transfer energy to theimplantable medical device. The energy transfer unit is operable by thepatient with less than three operative controls to control energytransfer from the external energy transfer unit to the implantablemedical device.

In another embodiment, the present invention provides an external energytransfer unit adapted to transcutaneously transfer energy to animplantable medical device for providing a therapeutic output to apatient. Energy transfer circuitry transcutaneously transfers energy tothe implantable medical device. Less than three operative controlscontrol energy transfer from the external energy transfer unit to theimplantable medical device.

In another embodiment, the present invention provides a method providinga therapeutic output to a patient with an implantable medical device. Anexternal energy transfer unit is operatively coupled with theimplantable medical device to transcutaneously transfer energy to theimplantable medical device. The energy transfer unit is controlled withless than three operative controls to control energy transfer from theexternal energy transfer unit to the implantable medical device.

In a preferred embodiment, the energy transfer unit is operable with twooperative controls to control energy transfer from the external energytransfer unit to the implantable medical device.

In a preferred embodiment, the two operative controls comprise a startcontrol and a stop control.

In a preferred embodiment, the start control is a start button andwherein the stop control is a stop button.

In a preferred embodiment, the energy transfer unit also has operativecontrols to start and stop the therapeutic output of the implantablemedical device.

In a preferred embodiment, the energy transfer unit also has a controlto enable and silence audio feedback from the energy transfer unit.

In a preferred embodiment, the external energy transfer unit inductivelycouples energy to the implantable medical device.

In a preferred embodiment, the implantable medical device has arechargeable energy storage device and wherein the energy transfer unitcharges the rechargeable energy storage device.

In another embodiment, the present invention provides an implantablemedical device system. An implantable medical device provides atherapeutic output to a patient. The implantable medical device iscapable of receiving inductively coupled energy with a secondary coiland is capable of being transcutaneously controlled using an internaltelemetry coil. An external antenna has a primary coil adapted toinductively transfer energy to the secondary coil of the implantablemedical device when the external antenna is externally placed inproximity of the secondary coil. An external energy transfer unit isadapted to be operatively coupled by a cord to the external antennadriving the primary coil to inductively transfer energy to theimplantable medical device. The energy transfer unit has an externaltelemetry coil allowing the energy transfer unit to communicate with theimplantable medical device through the internal telemetry coil in orderto at least partially control the therapeutic output of the implantablemedical device.

In another embodiment, the present invention provides an external energytransfer system adapted to transcutaneously transfer energy to animplantable medical device for providing a therapeutic output to apatient. The implantable medical device is capable of receivinginductively coupled energy with a secondary coil and is capable of beingtranscutaneously controlled using an internal telemetry coil. Anexternal antenna has a primary coil adapted to inductively transferenergy to the secondary coil of the implantable medical device when theexternal antenna is externally placed in proximity of the secondarycoil. An external energy transfer unit is adapted to be operativelycoupled by a cord to the external antenna driving the primary coil toinductively transfer energy to the implantable medical device. Theenergy transfer unit has an external telemetry coil allowing the energytransfer unit to communicate with the implantable medical device throughthe internal telemetry coil in order to at least partially control thetherapeutic output of the implantable medical device.

In another embodiment, the present invention provides a method ofcontrolling an implantable medical device for providing a therapeuticoutput. The implantable medical device is capable of receivinginductively coupled energy with a secondary coil and is capable of beingtranscutaneously controlled using an internal telemetry coil. Energy isinductively transferred to the secondary coil with an external antennahaving a primary coil when the external antenna is externally placed inproximity of the secondary coil. The primary coil is driven with anexternal energy transfer unit operatively coupled by a cord to theexternal antenna to inductively transfer energy to the implantablemedical device. An external telemetry coil in the energy transfer unitcommunicates with the implantable medical device through the internaltelemetry coil in order to at least partially control the therapeuticoutput of the implantable medical device.

In a preferred embodiment, the inductively transferring step and thecommunicating step occur simultaneously.

In a preferred embodiment, the energy transfer unit can control theimplantable medical device to turn the therapeutic output on and off.

In a preferred embodiment, the energy transfer unit can control theimplantable medical device using the external telemetry coil whiletransferring energy to the implantable medical using the primary coil ofthe antenna.

In a preferred embodiment, the implantable medical device has arechargeable energy storage device and wherein the energy transfer unitcharges the rechargeable energy storage device.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram of an external programmer and an externalcharging device for an implantable medical device such as can beutilized in the present invention;

FIG. 2 is a detailed block diagram of an implantable medical deviceimplanted sub-cutaneously and an associated external charging device inaccordance with an embodiment of the present invention;

FIG. 3 illustrates the start-up flow of an external programmer usable inconjunction with an implantable medical device;

FIG. 4 illustrates operation flow of an external programmer usable inconjunction with an implantable medical device;

FIG. 5 illustrates a therapy status screen of an external programmer;

FIG. 6 illustrates access to menu selection of an external programmer;

FIG. 7 illustrate group selections of an external programmer;

FIG. 8 illustrate parameter selections of an external programmer;

FIG. 9A illustrate screens of an external programmer;

FIG. 9B illustrate messages of an external programmer;

FIG. 9C illustrate warnings of an external programmer;

FIG. 10 illustrate menu selections of an external programmer;

FIG. 11 illustrates audio status of an external programmer;

FIG. 12 illustrates contrast of an external programmer;

FIG. 13 illustrates INS/ENS time of an external programmer;

FIG. 14 illustrate time/number formats of an external programmer;

FIG. 15 illustrate patient programmer information;

FIG. 16 illustrates INS/ENS information;

FIG. 16A illustrates Telemetry N information;

FIG. 17 illustrates the navigation flow of an external charger forrecharging the INS;

FIG. 18 illustrates the navigation flow of an external charger forrecharging the external power source;

FIG. 19 illustrates screen shots of charge status of an externalcharger;

FIG. 20 illustrates status messages displayed during charging of theINS;

FIG. 21 illustrates external power source charge status screens;

FIG. 22 illustrates status messages displayed during recharging of theexternal power source; and

FIGS. 23A and 23B illustrate screens, information messages and warnings.

DETAILED DESCRIPTION OF THE INVENTION

In FIG. 1, external programming unit 2 is attachable via cord 4 to anexternal telemetry coil 6. External programming unit 2 can programoperations implantable medical device 16 (FIG. 2) in a conventionalmanner using external telemetry coil 6. External antenna 52 isattachable via cord 56 to external charging device 48 is inductivelytransfer power to implantable medical device 16 when external antenna 52is placed in proximity of a secondary coil 24 associated withimplantable medical device 16. External charging device 48 receives ACpower from cord 8 through transformer 10. External antenna 52 can beheld in position on patient 18 with belt 12.

FIG. 2 illustrates an embodiment of implantable medical device 16situated under cutaneous boundary 38. Charging regulation and therapycontrol is conventional. Implantable medical device 16 also has internaltelemetry coil 44 configured in conventional manner to communicatethrough external telemetry coil 46 to an external programming device 2,charging unit 50 or other device in a conventional manner in order toboth program and control implantable medical device and to externallyobtain information from implantable medical device 16 once implantablemedical device has been implanted. Internal telemetry coil 44,rectangular in shape with dimensions of 1.85 inches (4.7 centimeters) by1.89 inches (4.8 centimeters) constructed from 150 turns of 43 AWG wire,is sized to be larger than the diameter of secondary charging coil 34.Secondary coil 34 is constructed with 182 turns of 30 AWG wire with aninside diameter of 0.72 inches (1.83 centimeters) and an outsidediameter of 1.43 inches (3.63 centimeters) with a height of 0.075 inches(0.19 centimeters). Magnetic shield 36 is positioned between secondarycharging coil 34 and housing 32 and sized to cover the footprint ofsecondary charging coil 34.

Internal telemetry coil 44, having a larger diameter than secondary coil34, is not completely covered by magnetic shield 36 allowing implantablemedical device 16 to communicate with the external programming devicewith internal telemetry coil 44 in spite of the presence of magneticshield 36.

Rechargeable power source 24 can be charged while implantable medicaldevice 16 is in place in a patient through the use of external chargingdevice 48. In a preferred embodiment, external charging device 48consists of charging unit 50 and external antenna 52. Charging unit 50contains the electronics necessary to drive primary coil 54 with anoscillating current in order to induce current in secondary coil 34 whenprimary coil 54 is placed in the proximity of secondary coil 34.Charging unit 50 is operatively coupled to primary coil by cable 56. Inan alternative embodiment, charging unit 50 and antenna 52 may becombined into a single unit. Antenna 52 also contains external telemetrycoil 46 which may be operatively coupled to charging unit 50 if it isdesired to communicate to or from implantable medical device 16 withexternal charging device 48. Alternatively, antenna 52 may containexternal telemetry coil 46 which can be operatively coupled to externalprogramming device 2, either individually or together with externalcharging unit 48.

The user interface of external programming unit 2 is illustrated byreference to FIG. 3 through FIG. 16. The following terms are usedthroughout the description of the user interface of external programmingunit 2.

As noted below in the explanation of acronyms utilized in the followingparagraphs and table, DTC refers to desktop charger which is used todenote the AC power supply (transformer 10) and power cord (cord 8). TheDTC is “docked” when external charger 48 is connected to an source of ACpower. The DTC is “undocked” when external charger 48 is disconnectedfrom a source of AC power.

-   DTC Desktop Charger-   ENS External Neurostimulator-   INS Implanted Neurostimulator-   INSR Another name for the RX1 Patient Recharger. Acronym stands for    Implanted Neurostimulator Recharger-   LCD Liquid Crystal Display

Refer to FIG. 3 and FIG. 4 for start-up flow and navigation flow,respectively.

User interface components in the keypad are shown below.

The LCD is backlit and consists of 96 (Horizontal)×58 (Vertical) dotswith asymmetrical dots 0.35 (H)×0.4 (V). The active area on the LCD is33.3 mm (H)×23.2 mm (V). Four colors of display available. These arenamed below (from lightest to darkest):

-   -   White    -   Light Gray    -   Dark Gray    -   Black

Icons are shown in Tables 1-6 below.

Therapy status screen display layout is divided vertically into threelines of information: status line, groups line and parameters line asshown in FIG. 5. When a successful initial interrogation has beenperformed, software will display the Therapy Status Screen of the activeset with the following highlighting priority: parameters line ifdisplayed; groups line if displayed; and status line.

Scroll up and scroll down keys will be used to access the status line,groups line and parameters line on the display. A box highlights userselection. Scroll left and right will be used to cycle through availablechoices for a selected line. Software will display a “real-time” INScharge level on the status line. The charge level will be updated anddisplayed whenever a parameter adjustment is made. Software will displayprogrammer battery status on the status line.

Access to Menu Selections is from the status line are shown in FIG. 6.Initial interrogation will include data on all groups currentlyavailable to the patient (“Baseline” setting).

Software will display labels for all groups the user can activate,including those containing no adjustable parameters. Refer to FIG. 7 forGroup Selections. All unnecessary text will be removed from the display:e.g., if there is only 1 group, software will not display the groupsline. Software will not display parameters that the user cannot adjust:i.e., the clinician programmer disallows access or upper and lowerlimits are the same. The user will access all available groups byscrolling through a linear list: A, B, C, . . . , Z. When the userscrolls to a different group, software will display the first adjustableparameter in the group. The user will scroll left/right throughavailable groups to access an inactive group.

Software will display all adjustable parameters for inactive groups. Theuser will scroll down to highlight parameters and scroll left or rightto view them. If a user presses Therapy Off or Therapy On when thescreen displays an inactive group, software will turn the INS off, anddisplay the Therapy Status Screen with the active group highlighted. Acheck in its check box will be used to indicate an active group(check_on); a check box without a check will be used to indicateinactive groups (check_off). The user will press the Sync key toactivate a group at the displayed parameter value(s).

The neurostimulator does not have to be on to activate a new group. Theuser can activate a group when therapy is off. The user can activate anew group when the groups line is highlighted or when the parametersline is highlighted. The check box will be updated whenever a new groupis activated.

Software will display labels for all parameters the user can adjust asshown in FIG. 8, Parameter Selections. Software will display the firstadjustable parameter of the active group when a Sync has been performedfor an initial interrogation. The user will access all adjustableparameters by scrolling through a linear list. The order of scrollingthrough adjustable parameters in a group is Amp1, Amp2, Amp3, Amp4, PW1,PW2, PW3, PW4, Rate, Amp1, . . . Refer to FIG. 8, Parameter Selections.Increase/decrease keys will be inactive until a session has beeninitiated—i.e., the INS has been interrogated. When the user presses andholds the increase/decrease keys, software will send a change to theneurostimulator every 12 second. When the user changes a parameter,software will display the updated parameter value.

Therapy control events are described in screens, information messagesand warnings that are displayed on the programmer as shown in FIGS. 9A,9B and 9C. Operational requirements are described in tables that specifyconditions for entry and expected changes in control. UserControl/System Event System Response: Table 10 reference Power DownScreen (blank display) Screen Entry: User Control/System Event Systemtimeout or Power Button keypress Power button Start Screen, 14, 15Therapy On 1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24Therapy Off 1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24 Sync1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24 Scrollup/down/Scroll left/right Ignore Increase/Decrease Ignore Replaceprogrammer batteries Splash Screen Start Screen Screen Entry: UserControl/System Event Power button Therapy On 1, 2, 3, 5, 6, 7, 8, 9, 11,12, 13, 14, 15, 20, 23, 24 Therapy Off 1, 2, 3, 5, 6, 7, 8, 9, 11, 12,13, 14, 15, 20, 23, 24 Sync 1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15,20, 23, 24 Power button/System timeout Power Down Screen Scrollup/down/Scroll left/right Ignore Increase/Decrease Ignore Increase +Decrease and hold 10 for 2-3 seconds Therapy Status Screen Screen Entry:User Control/System Event Telemetry success Therapy On 1, 2, 3, 4, 5, 6,7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24 Therapy Off 1, 2, 3, 4, 5, 6, 7,8, 9, 11, 12, 13, 14, 15, 20, 23, 24 Sync 1, 2, 3, 4, 5, 6, 7, 8, 9, 11,12, 13, 14, 15, 20, 23, 24 Increase 1, 2, 3, 4, 5, 6, 7, 8, 9, 11, 12,13, 14, 15, 17, 18, 19, 20, 23, 24 Decrease 1, 2, 3, 4, 5, 6, 7, 8, 9,11, 12, 13, 14, 15, 16, 19, 20, 23, 24 Scroll left/right from statusline Audio Screen, Time/Number Formats Power button/System timeout PowerDown Screen

The i symbol will be displayed on all information messages as shown inFIG. 9B. The user can clear all messages by pressing the 4-way button(Scroll up/down, Scroll left/right), Therapy Off to turn stimulation offor the Power button to turn the display off. If the system times out,the display will turn off (Power Down Screen). Refer to Table 7. TABLE 7Processing Requirements for Information Messages Message UserControl/System Response: Feedback/Next Screen INS Battery Low 4-waybutton: Therapy Status Stim Off: Table 10-1, 2, 3, 6, 11, 12, 13, 14,15, 23, 24 Stim On: ignore Sync: ignore Increase/Decrease: ignore Systemtimeout or Power button: Power Down ENS Battery Low 4-way button:Therapy Status Stim Off: Table 10-1, 2, 3, 8, 9, 12, 13, 14, 15, 20, 23,24 Stim On: ignore Sync: ignore Increase/Decrease: ignore System timeoutor Power button: Power Down Programmer Battery 4-way button: Previousscreen Low Stim Off: Table 10-1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 15,20, 23, 24 Stim On: ignore Sync: ignore Increase/Decrease: ignore Systemtimeout or Power button: Power Down Amp at Upper Limit 4-way button:Therapy Status Stim Off: Table 10-1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13,14, 15, 20, 23, 24 Stim On: ignore Sync: ignore Increase/Decrease:ignore System timeout or Power button: Power Down PW at Upper Limit4-way button: Therapy Status Stim Off: Table 10-1, 2, 3, 5, 6, 7, 8, 9,11, 12, 13, 14, 15, 20, 23, 24 Stim On: ignore Sync: ignoreIncrease/Decrease: ignore System timeout or Power button: Power DownRate at Upper Limit 4-way button: Therapy Status Stim Off: Table 10-1,2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24 Stim On: ignoreSync: ignore Increase/Decrease: ignore System timeout or Power button:Power Down Amp at Lower Limit 4-way button: Therapy Status Stim Off:Table 10-1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24 Stim On:ignore Sync: ignore Increase/Decrease: ignore System timeout or Powerbutton: Power Down PW at Lower Limit 4-way button: Therapy Status StimOff: Table 10-1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24Stim On: ignore Sync: ignore Increase/Decrease: ignore System timeout orPower button: Power Down Rate at Lower Limit 4-way button: TherapyStatus Stim Off: Table 10-1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15,20, 23, 24 Stim On: ignore Sync: ignore Increase/Decrease: ignore Systemtimeout or Power button: Power Down Poor Communication - Allow a repeatof the last keypress for Stim On, Sync, Increase and INS Decrease 4-waybutton: Sync Up Required Stim Off: Table 10-1, 2, 3, 5, 6, 11, 12, 13,14, 15 Stim On: Table 10-1, 2, 3, 5, 6, 11, 12, 13, 14, 15 Sync: Table10-1, 2, 3, 5, 6, 11, 12, 13, 14, 15 Increase/Decrease: Table 10-1, 2,3, 5, 6, 11, 12, 13, 14, 15, 16, 17, 18, 19 System timeout or Powerbutton: Power Down Poor Communication - Allow a repeat of the lastkeypress for Stim On, Sync, Increase and ENS Decrease 4-way button: SyncUp Required Stim Off: Table 10-2, 7, 8, 9, 12, 13, 14, 15, 20, 23, 24Stim On: Table 10-2, 7, 8, 9, 12, 13, 14, 15, 20, 23, 24 Sync: Table10-2, 7, 8, 9, 12, 13, 14, 15, 20, 23, 24 Increase/Decrease: Table 10-2,7, 8, 9, 12, 13, 14, 15, 16, 17, 18, 19, 20, 23, 24 System timeout orPower button: Power Down Sync Up 4-way button: Therapy Status Stim Off:Table 10-1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24 Stim On:Table 10-1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24 Sync:Table 10-1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20Increase/Decrease: ignore System timeout or Power button: Power DownTurn Stimulation On 4-way button: Therapy Status Stim Off: ignore StimOn: Table 10-1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24Sync: ignore Increase/Decrease: ignore System timeout or Power button:Power Down Connect ENS Cable 4-way button: Sync Up Required Stim Off:Table 10-2, 7, 8, 9, 12, 13, 14, 15, 20, 23, 24 Stim On: Table 10-2, 7,8, 9, 12, 13, 14, 15, 20, 23, 24 Sync: ignore Increase/Decrease: ignoreSystem timeout or Power button: Power Down

The exclamation mark symbol will be displayed on all warnings as shownin FIG. 9C. All warnings will remain on the display until the user takesappropriate action. Refer to Table 8. TABLE 8 Processing Requirementsfor Warning Messages User Action/System Response: MessageFeedback/NextScreen Recharge Stimulator System timeout or Power button:Power Down Replace ENS Battery System timeout or Power button: PowerDown Replace Programmer Replace programmer battery: Start Screen BatterySystem timeout or Power button: Power Down Sync Up Required Sync buttonor Therapy On or Therapy Off: Therapy Status System timeout or Powerbutton: Power Down Call Your Doctor Therapy Off and telemetry successwith audio feedback: Call Your Doctor Therapy Off and telemetry failurewith audio feedback: Call Your Doctor System timeout or Power button:Power Down Call Your Doctor - EOS System timeout or Power button: PowerDown Call Your Doctor - POR System timeout or Power button: Power Down

“In the box” messages are described in Table 9.

“In the Box” Messages

-   -   Software will notify the user with 3 beeps when “In the Box”        messages are displayed

All “In the Box” messages will remain on the display until the systemtimes out or the user presses the Power button to turn off the display.Refer to Table 9. TABLE 9 Processing Requirements for “In the Box”Messages User Action/System Response: Feedback/Next Message Screen INSin the Box System timeout or Power button: Power Down ENS in the BoxSystem timeout or Power button: Power Down

Therapy control events are described in Table 10. TABLE 10 ProcessingRequirements for Therapy Control Events and Device Communication UserControl/System Event System Response 1. Communicating with the INSDisplay Communicating - INS Message 2. Successful telemetry DisplayTherapy Status Screen 3. Telemetry failure - INS Display PoorCommunication - INS Message 4. Software is unable to refresh/update theDisplay Sync Up Required Warning Therapy Status Screen after a telemetryfailure 5. INS battery low Display INS Battery Low Message 6. INSbattery depleted Display Recharge Stimulator Warning 7. ENS battery lowor battery Display ENS Battery Low Message disconnected 8. ENS batterydepleted Display Replace ENS Battery Warning 9. ENS screening cabledisconnected Display Connect ENS Cable Message 10. User pressesIncrease + Decrease and Display Patient Information Screen holds for 2-3seconds (Error! Reference source not found.) 11. INS error - EOS DisplayCall Your Doctor - EOS Warning 12. INS error - battery voltage toohigh;/ Display Call Your Doctor Warning ENS error - POR, battery voltagetoo high 13. System Error and Warning Display Call Your Doctor Warning14. Patient programmer battery low Display Programmer Battery LowMessage 15. Patient programmer battery depleted Display ReplaceProgrammer Battery Warning 16. Parameter at lower limit Display At LowerLimit Message 17. Parameter at upper limit or out of reg Display AtUpper Limit Message 18. Increase with therapy off Display TurnStimulation On Message 19. Increase/decrease parameter of inactiveDisplay Sync Up Message group 20. ENS error - POR, battery voltage tooDisplay Communicating - ENS, low followed by INS/ENS Time with 12:00displayed 21. Communicating via IR Display IR Communication Screen 22.Replace programmer batteries Display Splash Screen 23. Communicatingwith the ENS Display Communicating - ENS Message 24. Telemetry failure -ENS Display Poor Communication - ENS Message 25. INS error - lockednormal Display INS in the Box Message 26. ENS error - ENS has noprograms or Display ENS in the Box Message groups 27. INS error - PORDisplay Call Your Doctor - POR Warning

Access to menu selections is from the status line on the Therapy Screenas shown in FIG. 10.

The display is divided vertically into two lines of information: menuoption line and value line. Scroll up and down keys will be used toaccess the menu option line and the value line on the display. A boxhighlights user selection. Scroll right and left and increase/decreasekeys will be used to change values for Audio, Contrast, Time/NumberFormat and the Information options. In addition, Increase/decrease keyswill be used to change values.

Software will display screens for the menu options in Table 11 MenuSelections. TABLE 111 Menu Selections and Navigation Flow Menu ItemReferences Audio FIG. 11, Table 12-1, 3, 9 Contrast FIG. 12, Table 12-1,3, 4, 6, 7, 9 INS/ENS Time FIG. 13, Table 12-1, 2, 4, 7, 8, 9Time/Number Format FIG. 14, Table 12-1, 3, 9 Patient ProgrammerInformation FIG. 15, Table 12-1, 2, 9, 10 INS/ENS Information FIG. 16,Table 12-1, 2, 9, 10 Telemetry N Information FIG. 16A, Table 12-1, 2, 9,10

The user interface of the external charger is described below. Adescription of the user interface for an external recharger for animplantable medical device is described. The appearance of the screensand how users interact with these screens are defined.

The following terms are used throughout the description of the userinterface for the external charger.

-   DTC Desktop Charger-   ENS External Neurostimulator-   INS Implanted Neurostimulator-   INSR Another name for the RX1 Patient Recharger. Acronym stands for    Implanted-   Neurostimulator Recharger-   LCD Liquid Crystal Display

Refer to FIG. 17 and FIG. 18 for navigation flow.

FIG. 17 illustrates a process for charging rechargeable power source 24in implantable medical device 16 by using external charging device 48.

In order to charge rechargeable power source 24, a patient may use belt12 to attach external antenna 52 to the patient's body at approximatelythe location of implanted medical device 16. It is desirable thatprimary coil 54 of external antenna 52 be aligned as closely as possiblewith secondary coil 34 of implantable medical device 16. Techniques forattaching external antenna 52 to the patient's body and positioningprimary coil 54 in close proximity to secondary coil 34 can be found inco-pending U.S. patent application Ser. No. 10/837,506, filed Apr. 30,2004, the entire contents of which are hereby incorporated by reference.This application claims priority from U.S. Provisional PatentApplication Ser. No. 60/508,174, filed Oct. 2, 2003.

After affixing external antenna 52 to the approximate location ofimplantable medical device 16, the patient (or other user such as amedical professional or family member assisting the patient) may thenpress (step 110) the “Start Charge” button 90 (FIG. 1) on charging unit50.

Charging unit 50 then determines (step 112) if telemetry withimplantable medical device 16 is successful. If telemetry isunsuccessful (step 114), an error message is generated such as atelemetry timeout (Reposition Antenna—Press Start Charge), system error(Antenna Too Hot) or external charging device 48 error due to INSRbattery low or INSR battery depleted and external charging devicedisplays the appropriate message. If telemetry is successful, thencharging unit 50 waits (step 116) and the appropriate charge status maybe indicated (step 118) in the display of charging unit 50.

If charging of rechargeable power source 24 is not yet complete (step120), charging unit 50 returns through step 118. The surface temperatureof antenna 52 is monitored as well as the charging current and batteryvoltage levels. An error message is generated and charging is suspendedif measurements are not within limits.

Once charging of rechargeable power 24 is complete (step 122), chargingunit 50 indicates in the display that charging is complete and the usermay press the “Stop Charge” button 92 on charging unit 50 to terminatethe charging process. Of course, it is to recognized and understood thatthe “Stop Charge” button 92 may be pressed at any time during thecharging process in order to terminate the charging process, i.e., theuser need not wait until the complete charging has been indicated.

Charging unit 50 may be operated to charge rechargeable power 24 inimplantable medical device 16 by the use of only two buttons, namely the“Start Charge” button 90 and the “Stop Charge” button 92. These are theonly two buttons which need be used. While a preferred embodiment ofcharging unit 50 does contain a third button, namely “Silence” button94, this third button is not necessary. “Silence” button 94 is used onlyto disable, or to re-enable, audio output of charging unit 50. Sinceaudio feedback is not required for the charging process, this button maybe used or not at the convenience of the user.

In an alternative embodiment, charging unit 50 may itself be powered bya rechargeable power source, such as a battery. Since the chargingprocess could take several hours, it would be desirable.

FIG. 18 illustrates the process used to charge the external chargingunit 48. The external charging unit 48 is connected (step 124) to asuitable power source, such as a readily available AC power outlet. Acheck is made (step 126) to determine whether a “recharge event”, i.e.,an alert or alarm condition, has occurred and, if so, issue theappropriate message (step 128). If a “recharge event” has not occurred,the process updates and displays (step 130) the charge status ofexternal charging device 48. If recharge of external charging is notcomplete (step 132), the process again updates and displays the chargingstatus in step 130. Once charging of external charging device 48 iscomplete (step 134), charging unit 50 displays a message indicative of acomplete charging process.

The LCD is backlit and consists of 96 (Horizontal)×58 (Vertical) dotswith asymmetrical dots 0.35 (H)×0.4 (V). The active area on the LCD is23.2 mm (V)×33.3 mm (H).

Four colors of display are available. These are named below (fromlightest to darkest):

-   -   White    -   Light Gray    -   Dark Gray    -   Black

The keypad has the following buttons.

The INS charge status screen display is divided vertically into threelines of information: status line, recharge progress line and rechargeefficiency line. Refer to FIG. 19 and FIG. 20.

Therapy On, Therapy Off, Start Charge and Stop Charge are dedicatedfunction keys. When the display is blank and the user presses TherapyOn, Therapy Off or Start Charge, software will perform the function andturn the display on. System timeout is <30 seconds.

The INS battery status display has 5 settings: 0%, 25%, 50%, 75% and100%. During recharge, software will display the appropriate quartilesin solid fill and the next higher quartile in a flashing on/off mannerevery second. The exception is 100%. Even if the INS battery voltageindicates 100%, software will flash the last quartile until the rechargesession is complete.

The INSR charge status screen display is divided vertically into twolines of information: status line and recharge progress line. Refer toFIG. 21, INSR Charge Status Screen, and FIG. 22, Recharging the INSR.

The INSR battery status has 5 settings: 0%, 25%, 50%, 75% and 100%.During recharge, software will display the appropriate quartiles insolid fill and the next higher quartile in a flashing on/off mannerevery second. The exception is 100%. Even if the INSR battery voltageindicates 100%, software will flash the last quartile until the rechargesession is complete.

Recharging events are described in screens, information messages andwarnings that are displayed on the recharger as shown in FIG. 23A andFIG. 23B. Operational requirements are described in tables that specifyconditions for entry and expected changes in control. Refer to theoperational requirements for each screen in this section.

The i symbol will be displayed on all information messages. With theexception of INSR System Information screen, the user can exit themessages by pressing Audio or wait for the system to timeout. Therapy Onand Off will always be active when the messages are displayed. When theuser presses Therapy On or Off, software will turn stimulation on/offand clear the information message.

The exclamation mark symbol will be displayed on all warnings. Allwarnings will remain on the display until the user takes appropriateaction. 1-Power Down Screen (blank display) Screen Entry: UserControl/System Event System timeout from Start Screen - Not Docked UserControl/ System Event System Response: Feedback/Next Screen(requirement) Therapy On/Off Telemetry success: Start Screen - NotDocked with Therapy On/Off icon on status line (Table 17-22) Telemetryevent: refer to Table 18 Start Charge Antenna temperature OK: WaitScreen (Table 17-1) Antenna too hot: Antenna Too Hot Message (Table17-30) Antenna failure: Call Your Doctor Warning (Table 17-18) Antennadisconnected: Connect INSR Antenna Message (Table 17-14) INSR batterylow: INSR Battery Low Message (Table 17-8) INSR battery depleted:Recharge INSR Warning (Table 17-9) Stop Charge No change Audio StartScreen - Not Docked (Table 17-24, 25) INSR battery low: INSR Battery LowMessage (Table 17-8) INSR battery depleted: Recharge INSR Warning (Table17-9) Attach DTC INSR recharge complete: INSR Recharge Complete Message(Table 17-11) INSR recharge incomplete: INSR Charge Status Screen (Table17-7) Audio + Stop Charge INSR System Information Message (Table 17-17)Audio + Start Charge Antenna temperature OK: Physician Recharge Screen(Table 17- and hold for >10 21) seconds Antenna too hot: PhysicianRecharge - Antenna Too Hot (Table 17-31) 2-Start Screen - Not DockedScreen Entry: User Control/System Event Therapy On/Off keys when therecharger is powered down Audio key when the recharger is powered downAny key from Splash Screen Detach DTC System timeout or message clearwhen DTC is detached Stop Charge from Physician Recharge Screen orPhysician Recharge - Antenna Too Hot Screen Host terminates the session,the Reset button is activated or the user presses Audio from IRCommunication Screen User Control/ System Event System Response:Feedback/Next Screen (requirement) Therapy On/Off Telemetry success:Therapy On/Off icon on status line (Table 17-22) Telemetry event: referto Table 18 Start Charge Antenna temperature OK: Wait Screen (Table17-1) Antenna too hot: Antenna Too Hot Message (Table 17-30) Antennafailure: Call Your Doctor Warning (Table 17-18) Antenna disconnected:Connect INSR Antenna Message (Table 17-14) INSR battery low: INSRBattery Low Message (Table 17-8) INSR battery depleted: Recharge INSRWarning (Table 17-9) Stop Charge No change Audio Audio icon (Table17-24) INSR battery low INSR Battery Low Message (Table 17-8) INSRbattery depleted Recharge INSR Warning (Table 17-9) System error CallYour Doctor Warning (Table 17-18) Attach DTC INSR recharge complete:INSR Recharge Complete Message (Table 17-11) INSR recharge incomplete:INSR Charge Status Screen (Table 17-7) Audio + Stop Charge INSR SystemInformation Message (Table 17-17) Audio + Start Charge Antennatemperature OK: Physician Recharge Screen (Table and hold for >10 17-21)seconds Antenna too hot: Physician Recharge - Antenna Too Hot (Table17-31) System timeout Power Down Screen 3-Start Screen - Docked ScreenEntry: User Control/System Event System timeout or message clear Any keyfrom Splash Screen Host terminates the session, the Reset button isactivated or the user presses Audio from the Splash Screen Stop Chargefrom Physician Recharge Screen or Physician Recharge - Antenna Too HotScreen User Control/ System Event System Response: Feedback/Next Screen(requirement) Therapy On/Off Telemetry success: Therapy On/Off icon onstatus line (Table 17-22) Telemetry event: refer to Table 18 StartCharge Antenna temperature OK: Wait Screen (Table 17-1) Antenna too hot:Antenna Too Hot Message (Table 17-30) Antenna failure: Call Your DoctorWarning (Table 17-18) Antenna disconnected: Connect INSR Antenna (Table17-14) Stop Charge No change Audio Audio icon (Table 17-24) System errorCall Your Doctor Warning (Table 17-18) Detach DTC Start Screen - NotDocked Audio + Stop Charge INSR System Information Message (Table 17-17)Audio + Start Charge Antenna temperature OK: Physician Recharge Screen(Table and hold for >10 17-21) seconds Antenna too hot: PhysicianRecharge - Antenna Too Hot (Table 17-31) 4-Wait Screen Screen Entry:User Control/System Event Start Charge Antenna temperature OK Systemtimeout or message clear User Control/ System Event System Response:Feedback/Next Screen (requirement) Therapy On/Off No change Telemetrysuccess INS Charge Status Screen or INS Charge Status - 90 to 100%Screen (Table 17-2) Telemetry failure or Reposition Antenna - PressStart Charge Warning (Table 17-12) poor charging condition INS error:ERI Call Your Doctor - ERI Message (Table 17-19) INS error: POR CallYour Doctor - POR Message (Table 17-27) INS error: EOS, battery CallYour Doctor Warning (Table 17-18) voltage too high INSR battery low INSRBattery Low Message (Table 17-8) INSR battery depleted Recharge INSRWarning (Table 17-9) Antenna too hot INS Charge Status - Antenna Too Hot(Table 17-13) Antenna failure Call Your Doctor Warning (Table 17-18)Antenna disconnected Connect INSR Antenna Message (Table 17-14) Systemerror Call Your Doctor Warning (Table 17-18) Start Charge No change StopCharge (not Start Screen - Not Docked docked) Stop Charge (docked) INSRrecharge incomplete: INSR Charge Status Screen (Table 17-7) INSRrecharge complete: INSR Recharge Complete Message (Table 17-11) Audio Nochange Attach DTC No change Detach DTC No change Audio + Stop Charge Nochange Audio + Start Charge No change and hold for >10 seconds 5-INSCharge Status Screen Screen Entry: User Control/System Event Telemetrysuccess System timeout or message clear Antenna temperature OK UserControl/ System Event System Response: Feedback/Next Screen(requirement) Therapy On/Off Telemetry success: Therapy On/Off icon onstatus line (Table 17-22) Telemetry event: refer to Table 18 StartCharge Antenna temperature OK: refresh recharge efficiency line (Table17-26) Antenna too hot: INS Charge Status - Antenna Too Hot (Table17-13) Stop Charge Charge complete: INS Recharge Complete Message (Table17- 6) Charge incomplete and not INS battery low: INS RechargeInterrupted Message (Table 17-5) INS battery low: INS Battery LowMessage (Table 17-3) INS battery depleted: Recharge Stimulator Warning(Table 17- 4) Audio Toggle Audio icon (Table 17-24) Attach DTC Powersource symbol on status line (Table 17-23) Detach DTC INSR battery low:INSR Battery Low Message (Table 17-8) INSR battery depleted: RechargeINSR Warning (Table 17-9) Status line without power source symbol (Table17-23) INS recharge complete INS Recharge Complete Message (Table 17-6)INS error: ERI Call Your Doctor ERI Message (Table 17-19) INS error: PORCall Your Doctor - POR Message (Table 17-27) INS error: EOS, batteryCall Your Doctor Warning (Table 17-18) voltage too high Antenna too hotINS Charge Status - Antenna Too Hot (Table 17-13) Antenna failure CallYour Doctor Warning (Table 17-18) Antenna disconnected Connect INSRAntenna Message (Table 17-14) INSR battery low INSR Battery Low Message(Table 17-8) INSR battery depleted Recharge INSR Warning (Table 17-9)INSR recharge INSR Batt1 on status line (Table 17-25) complete Systemerror Call Your Doctor Warning (Table 17-18) Audio + Stop Charge Nochange Audio + Start Charge No change and hold for >10 seconds 6-INSRCharge Status Screen Screen Entry: User Control/System Event Attach DTCfrom Power Down Screen, Start Screen - Not Docked or Recharge INSRWarning Attach DTC from INSR Battery Low Message when not charging INSSystem timeout or message clear User Control/ System Event SystemResponse: Feedback/Next Screen (requirement) Therapy On/Off Telemetrysuccess: Therapy On/Off icon on status line (Table 17-22) Telemetryevent: refer to Table 18 Start Charge Antenna temperature OK: WaitScreen (Table 17-1) Antenna too hot: Antenna Too Hot Message (Table17-30) Audio Toggle Audio icon (Table 17-24) Detach DTC Chargeincomplete and not INSR battery low: INSR Recharge Interrupted Message(Table 17-10) INSR battery low: INSR Battery Low Message (Table 17-8)INSR battery depleted: Recharge INSR Warning (Table 17-9) INSR rechargecomplete: INSR Recharge Complete Message (Table 17-11) INSR rechargeINSR Recharge Complete Message (Table 17-11) complete Audio + StartCharge Antenna temperature OK: Physician Recharge Screen (Table and holdfor >10 17-21) seconds Antenna too hot: Physician Recharge - Antenna TooHot (Table 17-31) System error Call Your Doctor Warning (Table 17-18)7-Physician Recharge Screen Screen Entry: User Control/System EventAudio + Start Charge and hold for >10 seconds Antenna temperature OKSystem timeout or message clear User Control/ System Event* SystemResponse: Feedback/Next Screen (requirement) Successful INS ChargeStatus Screen (Table 17-2) communication with INS Timer goes to zero andStart Screen - Not Docked without Therapy On/Off icon on system timesout (not status line (Table 17-22) docked) Timer goes to zero and INSRrecharge incomplete: INSR Charge Status Screen system times out (Table17-7) (docked) INSR recharge complete: INSR Recharge Complete Message(Table 17-11) Stop Charge (not Start Screen - Not Docked docked) StopCharge (docked) Start Screen - Docked Detach DTC INSR battery low: INSRBattery Low Message (Table 17-8) INSR battery depleted: Recharge INSRWarning (Table 17-9) Antenna too hot Physician Recharge - Antenna TooHot (Table 17-31) Antenna failure Call Your Doctor Warning (Table 17-18)Antenna disconnected Connect INSR Antenna Message (Table 17-14) Systemerror Call Your Doctor Warning (Table 17-18) INSR battery low INSRBattery Low Message (Table 17-8) INSR battery depleted Recharge INSRWarning (Table 17-9) INSR recharge No change complete 8-IR CommunicationScreen Screen Entry: User Control/System Event Reset button from anyscreen when DTC is not docked and IR command is received ProcessingRequirements All keys inactive Software will display the screen untilthe host terminates the session, the Reset button is activated or theAudio key is pressed. (Table 17-28) When the host terminates the sessionor the Reset button is activated, software will display Start Screen -Not Docked. 9-INS Battery Low Message Screen Entry: User Control/SystemEvent Therapy On/Off Entry Screen User Control/System Event: Next ScreenPower Down Audio key or system timeout: Start Screen - Not Docked withStart Screen - Not Therapy On/Off icon on status line (Table 17-22)Docked Therapy On/Off and telemetry success: Start Screen - Not Dockedwith Therapy On/Off icon on status line (Table 17- 22) Therapy On/Offand telemetry event: Refer to Table 18 Start Charge and antennatemperature OK: Wait Screen (Table 17-1) Start Charge and antenna toohot: Antenna Too Hot Message (Table 17-30) Stop Charge: no change AttachDTC: no change Start Screen - Docked Audio key or system timeout: StartScreen - Docked with Therapy On/Off icon on status line (Table 17-22)Therapy On/Off and telemetry success: Start Screen - Docked with TherapyOn/Off icon on status line (Table 17-22) Therapy On/Off and telemetryevent: Refer to Table 18 Start Charge and antenna temperature OK: WaitScreen (Table 17-1) Start Charge and antenna too hot: Antenna Too HotMessage (Table 17-30) Stop Charge: no change Detach DTC: no change INSRCharge Status Audio key or system timeout: INSR Charge Status Screenwith Therapy On/Off icon on status line (Table 17-22) Therapy On/Off andtelemetry success: INSR Charge Status with Therapy On/Off icon on statusline (Table 17-22) Therapy On/Off and telemetry event: Refer to Table 18Start Charge and antenna temperature OK: Wait Screen/INS Charge Status(Table 17-1) Start Charge and antenna too hot: Antenna Too Hot Message(Table 17-30) Stop Charge: no change Detach DTC: no change INS BatteryLow Message - continued Screen Entry: User Control/System Event StopCharge Entry Screen User Control/System Event: Next Screen INS ChargeStatus Audio key or system timeout: Start Screen - Not Docked (notdocked) Therapy On/Off and telemetry success: Start Screen - Not Dockedwith Therapy On/Off icon on status line (Table 17-22) Therapy On/Off andtelemetry event: Refer to Table 18 Start Charge and antenna temperatureOK: Wait Screen (Table 17-1) Start Charge and antenna too hot: AntennaToo Hot Message (Table 17-30) Stop Charge: no change Attach DTC: nochange INS Charge Status Audio key and INSR recharge incomplete: INSRCharge Status (docked) with Therapy On/Off icon on status line (Table17-22) Audio key and INSR recharge complete: INSR Recharge CompleteMessage (Table 17-11) Therapy On/Off and telemetry success and INSRrecharge incomplete: INSR Charge Status with Therapy On/Off icon onstatus line (Table 17-22) Therapy On/Off and telemetry success and INSRrecharge complete: Start Screen - Docked with Therapy On/Off icon onstatus line (Table 17-22) Therapy On/Off and telemetry event: Refer toTable 18 Start Charge and antenna temperature OK: Wait Screen (Table17-1) Start Charge and antenna too hot: Antenna Too Hot Message (Table17-30) Stop Charge: no change Detach DTC: no change 10-INS RechargeInterrupted Message Screen Entry: User Control/System Event Stop ChargeEntry Screen User Control/System Event: Next Screen INS Charge StatusAudio key or system timeout: Start Screen - Not Docked (not docked)Therapy On/Off and telemetry success: Start Screen - Not Docked withTherapy On/Off icon on status line (Table 17-22) Therapy On/Off andtelemetry event: Refer to Table 18 Start Charge and antenna temperatureOK: Wait Screen (Table 17-1) Start Charge and antenna too hot: AntennaToo Hot Message (Table 17-30) Stop Charge: no change Attach DTC: nochange INS Charge Status Audio key or system timeout and INSR rechargeincomplete: (docked) INSR Charge Status with Therapy On/Off icon onstatus line (Table 17-22) Audio key or system timeout and INSR rechargecomplete: INSR Recharge Complete Message (Table 17-11) Therapy On/Offand telemetry success and INSR recharge incomplete: INSR Charge Statuswith Therapy On/Off icon on status line (Table 17-22) Therapy On/Off andtelemetry success and INSR recharge complete: Start Screen - Docked withTherapy On/Off icon on status line (Table 17-22) Therapy On/Off andtelemetry event: Refer to Table 18 Start Charge and antenna temperatureOK: Wait Screen (Table 17-1) Start Charge and antenna too hot: AntennaToo Hot Message (Table 17-30) Stop Charge: no change Detach DTC: nochange 11-INS Recharge Complete Message Screen Entry: UserControl/System Event Stop Charge INS recharge complete Entry Screen UserControl/System Event: Next Screen INS Charge Status Audio key or systemtimeout: Start Screen - Not Docked (not docked) Therapy On/Off andtelemetry success: Start Screen - Not INS Charge Status - Docked withTherapy On/Off icon on status line (Table 17-22) 90 to 100% (not TherapyOn/Off and telemetry event: Refer to Table 18 docked) Start Charge andantenna temperature OK: Wait Screen (Table 17-1) Start Charge andantenna too hot: Antenna Too Hot Message (Table 17-30) Stop Charge: nochange Attach DTC: no change INS Charge Status Audio key or systemtimeout and INSR recharge incomplete: (docked) INSR Charge Status INSCharge Status - Audio key or system timeout and INSR recharge complete:90 to 100% (docked) INSR Recharge Complete Message (Table 17-11) TherapyOn/Off and telemetry success and INSR recharge incomplete: INSR ChargeStatus with Therapy On/Off icon on status line (Table 17-22) TherapyOn/Off and telemetry success and INSR recharge complete: Start Screen -Docked with Therapy On/Off icon on status line (Table 17-22) TherapyOn/Off and telemetry event: Refer to Table 18 Start Charge and antennatemperature OK: Wait Screen (Table 17-1) Start Charge and antenna toohot: Antenna Too Hot Message (Table 17-30) Stop Charge: no change DetachDTC: no change 12-INSR Battery Low Message Screen Entry: UserControl/System Event Therapy On/Off Entry Screen User Control/SystemEvent: Next Screen Power Down Audio key or system timeout: StartScreen - Not Docked with Start Screen - Not Therapy On/Off icon onstatus line (Table 17-22) Docked Therapy On/Off and telemetry success:Start Screen - Not Docked with Therapy On/Off icon on status line (Table17-22) Therapy On/Off and telemetry event: Refer to Table 18 StartCharge and antenna temperature OK: Wait Screen (Table 17-1) Start Chargeand antenna too hot: Antenna Too Hot Message (Table 17-30) Stop Charge:no change Attach DTC: INSR Charge Status with Therapy On/Off icon onstatus line (Table 17-23) INS Charge Status Audio key or system timeout:previous screen with Therapy INS Charge Status - On/Off icon on statusline (Table 17-22) 90 to 100% Therapy On/Off and telemetry success: WaitScreen Therapy On/Off and telemetry event: Refer to Table 18 StartCharge and antenna temperature OK: Wait Screen (Table 17-1) Start Chargeand antenna too hot: INS Charge Status - Antenna Too Hot Screen (Table17-13) Stop Charge: Start Screen - Not Docked Attach DTC: previousscreen with Therapy On/Off icon and Power Source Symbol on status line(Table 17-22, 23) Screen Entry: User Control/System Event Start ChargeEntry Screen User Control/System Event: Next Screen Power Down Audio keyor system timeout: Wait Screen/INS Charge Status/ Start Screen - Not INSCharge Status - 90 to 100% Docked Therapy On/Off and telemetry success:Wait Screen/INS Charge/INS Charge Status - 90 to 100% Status withTherapy On/Off icon on status line (Table 17-22) Therapy On/Off andtelemetry event: Refer to Table 18 Start Charge and antenna temperatureOK: Wait Screen (Table 17-1) Start Charge and antenna too hot: AntennaToo Hot Message (Table 17-30) Stop Charge: no change Attach DTC: WaitScreen/INS Charge Status/INS Charge Status - 90 to 100% INSR Battery LowMessage - continued Screen Entry: User Control/System Event Audio EntryScreen User Control/System Event: Next Screen Power Down Audio key orsystem timeout: Start Screen - Not Docked Therapy On/Off and telemetrysuccess: Start Screen - Not Docked with Therapy On/Off icon on statusline (Table 17-22) Therapy On/Off and telemetry event: Refer to Table 18Attach DTC: INSR Charge Status Screen Entry: User Control/System EventINSR battery low condition Entry Screen User Control/System Event: NextScreen Wait Screen Audio key or system timeout or Attach DTC: WaitScreen/INS Charge Status/INS Charge Status - 90 to 100% PhysicianRecharge Audio key or system timeout or Attach DTC: Physician RechargePhysician Recharge - Audio key or system timeout or Attach DTC:Physician Recharge - Antenna Too Hot Antenna Too Hot INS Charge StatusAudio key or system timeout or Attach DTC: INS Charge Status INS ChargeStatus 90 to Audio key or system timeout or Attach DTC: INS ChargeStatus - 90 100% to 100% INS Charge Status - Audio key or system timeoutor Attach DTC: INS Charge Status - Antenna Too Hot Antenna Too Hot StartScreen - Not Audio key or system timeout: Start Screen - Not DockedDocked Attach DTC: INSR Charge Status INSR Battery Low Message -continued Screen Entry: User Control/System Event Detach DTC EntryScreen User Control/System Event: Next Screen INS Charge Status Audiokey or system timeout: previous screen INS Charge Status - TherapyOn/Off and telemetry success: previous screen with 90 to 100% TherapyOn/Off icon on status line (Table 17-22) INS Charge Status - TherapyOn/Off and telemetry event: Refer to Table 18 Antenna Too Hot StartCharge and antenna temperature OK: Wait Screen (Table 17-1) Start Chargeand antenna too hot: INS Charge Status - Antenna Too Hot Screen (Table17-13) Stop Charge: Start Screen - Not Docked Attach DTC: previousscreen with power source symbol on status line (Table 17-23) INSR ChargeStatus Audio key or system timeout: Start Screen - Not Docked TherapyOn/Off and telemetry success: Start Screen - Not Docked with TherapyOn/Off icon on status line (Table 17-22) Therapy On/Off and telemetryevent: Refer to Table 18 Start Charge and antenna temperature OK: WaitScreen (Table 17-1) Start Charge and antenna too hot: Antenna Too HotMessage (Table 17-30) Stop Charge: no change Attach DTC: INSR ChargeStatus Physician Recharge Audio key or system timeout: previous screenScreen Therapy On/Off: no change Physician Recharge - Start Charge: nochange Antenna Too Hot Stop Charge: Start Screen - Not Docked AttachDTC: previous screen 13-INSR Recharge Interrupted Message Screen Entry:User Control/System Event Detach DTC Entry Screen User Control/SystemEvent: Next Screen INSR Charge Audio key or system timeout: StartScreen - Not Docked Status Therapy On/Off and telemetry success: StartScreen - Not Docked with Therapy On/Off icon on status line (Table17-22) Therapy On/Off and telemetry event: Refer to Table 18 StartCharge and antenna temperature OK: Wait Screen (Table 17- 1) StartCharge and antenna too hot: Antenna Too Hot Message (Table 17-30) StopCharge: no change Attach DTC: INSR Charge Status 14-INSR RechargeComplete Message Screen Entry: User Control/System Event INSR rechargecomplete Entry Screen User Control/System Event: Next Screen INSR ChargeStatus Audio key: Start Screen - Docked Therapy On/Off and telemetrysuccess: Start Screen - Docked with Therapy On/Off icon on status line(Table 17-22) Therapy On/Off and telemetry event: Refer to Table 18Start Charge and antenna temperature OK: Wait Screen (Table 17-1) StartCharge and antenna too hot: Antenna Too Hot Message (Table 17-30) StopCharge: no change Detach DTC: Start Screen - Not Docked Screen Entry:User Control/System Event Attach DTC Entry Screen User Control/SystemEvent: Next Screen Power Down Audio key: Start Screen - Docked StartScreen - Not Therapy On/Off and telemetry success: Start Screen - DockedDocked with Therapy On/Off icon on status line (Table 17-22) TherapyOn/Off and telemetry event: Refer to Table 18 Start Charge and antennatemperature OK: Wait Screen (Table 17-1) Start Charge and antenna toohot: Antenna Too Hot Message (Table 17-30) Stop Charge: no change DetachDTC: Start Screen - Not Docked 15-INSR System Information Message ScreenEntry: User Control/System Event Audio + Stop Charge Entry Screen UserControl/System Event: Next Screen Power Down Audio key: Cycle throughinformation Start Screen - Not Stop Charge or System timeout and notdocked: Start Screen - Docked Not Docked Start Screen - Stop Charge orSystem timeout and docked: Start Screen - Docked Docked Therapy On/Offand telemetry success: Start Screen - Not Docked with Therapy On/Officon on status line (Table 17-22) Therapy On/Off and telemetry event:Refer to Table 18 Start Charge and antenna temperature OK: Wait Screen(Table 17-1) Start Charge and antenna too hot: Antenna Too Hot Message(Table 17-30) Attach/Detach DTC: no change 16-Call Your Doctor - ERIMessage Screen Entry: User Control/System Event Therapy On/Off EntryScreen User Control/System Event: Next Screen Power Down Audio key orsystem timeout: Start Screen - Not Docked with Start Screen - NotTherapy On/Off icon on status line (Table 17-22) Docked Therapy On/Offand telemetry success: Start Screen - Not Docked with Therapy On/Officon on status line (Table 17-22) Therapy On/Off and telemetry event:Refer to Table 18 Start Charge and antenna temperature OK: Wait Screen(Table 17-1) Start Charge and antenna too hot: Antenna Too Hot Message(Table 17-30) Stop Charge/Attach DTC: no change INS Charge Status Audiokey or system timeout: previous screen with Therapy INS Charge Status -On/Off icon on status line (Table 17-22) 90 to 100% Therapy On/Off andtelemetry success: previous screen with INS Charge Status - TherapyOn/Off icon on status line (Table 17-22) Antenna Too Hot Therapy On/Offand telemetry event: Refer to Table 18 Start Charge and antennatemperature OK: Wait Screen (Table 17-1) Start Charge and antenna toohot: INS Charge Status - Antenna Too Hot Screen (Table 17-13) StopCharge and not docked: Start Screen - Not Docked Stop Charge and docked:Start Screen - Docked Attach DTC/Detach DTC: no change INSR ChargeStatus Audio key or system timeout: INSR Charge Status Screen withTherapy On/Off icon on status line (Table 17-22) Therapy On/Off andtelemetry success: INSR Charge Status with Therapy On/Off icon on statusline (Table 17-22) Therapy On/Off and telemetry event: Refer to Table 18Start Charge and antenna temperature OK: Wait Screen (Table 17-1) StartCharge and antenna too hot: Antenna Too Hot Message (Table 17-30) StopCharge/Detach DTC: no change Start Screen - Docked Audio key or systemtimeout: Start Screen - Docked with Therapy On/Off icon on status line(Table 17-22) Therapy On/Off and telemetry success: Start Screen -Docked with Therapy On/Off icon on status line (Table 17-22) TherapyOn/Off and telemetry event: Refer to Table 18 Start Charge and antennatemperature OK: Wait Screen (Table 17-1) Start Charge and antenna toohot: Antenna Too Hot Message (Table 17-30) Stop Charge/Detach DTC: nochange Call Your Doctor - ERI continued Screen Entry: UserControl/System Event INS error: ERI Entry Screen User Control/SystemEvent: Next Screen Wait Screen Audio key or system timeout: Wait ScreenTherapy On/Off and telemetry success: Wait Screen Therapy On/Off andtelemetry event: Refer to Table 18 Start Charge and antenna temperatureOK: Wait Screen (Table 17-1) Start Charge and antenna too hot: INSCharge Status - Antenna Too Hot Screen (Table 17-13) Stop Charge/AttachDTC/Detach DTC: no change INS Charge Status Audio key or system timeout:previous screen INS Charge Status - Therapy On/Off and telemetrysuccess: previous screen with 90 to 100% Therapy On/Off icon on statusline (Table 17-22) INS Charge Status - Therapy On/Off and telemetryevent: Refer to Table 18 Antenna Too Hot Start Charge and antennatemperature OK: Wait Screen (Table 17-1) Start Charge and antenna toohot: INS Charge Status - Antenna Too Hot Screen (Table 17-13) StopCharge and not docked: Start Screen - Not Docked Stop Charge and docked:Start Screen - Docked Attach DTC/Detach DTC: no change 17-Call YourDoctor - POR Message Screen Entry: User Control/System Event TherapyOn/Off Entry Screen User Control/System Event: Next Screen Power DownAudio key or system timeout: Start Screen - Not Docked Start Screen -Not with Therapy On/Off icon on status line (Table 17-22) Docked TherapyOn/Off: no change Start Charge/Stop Charge/Attach DTC/Detach DTC: nochange INS Charge Status Audio key or system timeout: previous screenwith Therapy INS Charge Status - On/Off icon on status line (Table17-22) 90 to 100% Therapy On/Off: no change INS Charge Status - StopCharge and not docked: Start Screen - Not Docked Antenna Too Hot StopCharge and docked: Start Screen - Docked Start Charge/Attach DTC/DetachDTC: no change INSR Charge Status Audio key or system timeout: INSRCharge Status Screen with Therapy On/Off icon on status line (Table17-22) Therapy On/Off: no change Start Charge/Stop Charge/AttachDTC/Detach DTC: no change Start Screen - Docked Audio key or systemtimeout: Start Screen - Docked with Therapy On/Off icon on status line(Table 17-22) Therapy On/Off: no change Start Charge/Stop Charge/AttachDTC/Detach DTC: no change Screen Entry: User Control/System Event INSerror: POR Entry Screen User Control/System Event: Next Screen WaitScreen Audio key or system timeout: Wait Screen Therapy On/Off andtelemetry success: Wait Screen Therapy On/Off and telemetry event: Referto Table 18 Start Charge and antenna temperature OK: Wait Screen (Table17-1) Start Charge and antenna too hot: Antenna Too Hot Message (Table17-30) Stop Charge/Attach DTC/Detach DTC: no change INS Charge StatusAudio key or system timeout: previous screen INS Charge Status - TherapyOn/Off and telemetry success: previous screen with 90 to 100% INSTherapy On/Off icon on status line (Table 17-22) Charge Status - TherapyOn/Off and telemetry event: Refer to Table 18 Antenna Too Hot StopCharge and not docked: Start Screen - Not Docked Stop Charge and docked:Start Screen - Docked Start Charge/Attach DTC/Detach DTC: no change18-Antenna Too Hot Message Screen Entry: User Control/System Event StartCharge Entry Screen User Control/System Event: Next Screen Power DownAudio key or system timeout and not docked and antenna too StartScreen - hot: Start Screen - Not Docked Docked Audio key or systemtimeout and docked and antenna too hot: Start Screen - Not StartScreen - Docked Docked Audio key or system timeout and docked/not dockedand INSR Charge antenna cools: INS Charge Status/INS Charge Status - 90to Status 100% INS Battery Low Therapy On/Off and telemetry success andnot docked: Start INS Recharge Screen - Not Docked with Therapy On/Officon on status line Interrupted (Table 17-22) INS Recharge TherapyOn/Off and telemetry success and docked: Start Complete Screen - Dockedwith Therapy On/Off icon on status line INSR Battery Low (Table 17-22)INSR Recharge Therapy On/Off and telemetry event: Refer to Table 18Interrupted Start Charge: no change INSR Recharge Stop Charge and chargecomplete: INS Recharge Complete Complete Message (Table 17-6) Call YourDoctor - Stop Charge and charge incomplete and not INS battery low: ERIINS Recharge Interrupted Message (Table 17-5) Call Your Doctor - StopCharge and INS battery low: INS Battery Low Message POR Reposition(Table 17-3) Antenna - Press Stop Charge and INS battery depleted:Recharge Stimulator Start Charge Warning (Table 17-4) WarningAttach/detach DTC: no change Connect INSR Antenna 19-Warning MessagesWarning User Control/System Event: Next Screen Recharge Stimulator StartCharge and antenna temperature OK: Wait Screen (Table 17-1) Start Chargeand antenna too hot: Antenna Too Hot Message (Table 17-30) Systemtimeout: Power Down Recharge INSR Attach DTC: INSR Charge Status Screenwith Power Source Symbol System timeout: Power Down Reposition Antenna -Start Charge and antenna temperature OK: Wait Screen (Table Press StartCharge 17-1) Start Charge and antenna too hot: Antenna Too Hot Message(Table 17-30) System timeout: Power Down Reposition Antenna - TherapyOff and telemetry success: Start Screen - Docked or Press Therapy OffStart Screen - Not Docked with Therapy Off icon on status line (Table17-22) Therapy Off and telemetry event: refer to Table 18 Systemtimeout: Power Down Reposition Antenna - Therapy On and telemetrysuccess: Start Screen - Docked or Press Therapy On Start Screen - NotDocked with Therapy On icon on status line (Table 17-22) Therapy On andtelemetry event: refer to Table 18 System timeout: Power Down Call YourDoctor System timeout: Power Down Call Your Doctor - System timeout:Power Down EOS 20-Splash Screen Screen Entry: User Control/System EventApplication is loading Reset button is activated and application isreloading Processing Requirements All keys active Software will displaythe screen until the user presses any key or the system times out. Whenthe user presses any key or the system times out, software will displaythe Start Screen - Docked or Start Screen - Not Docked (Table 17-29)21-Connect INSR Antenna Message Screen Entry: User Control/System EventAntenna disconnected User Control/System Event: Next Screen (assumingantenna Entry Screen and recharger are making full contact) Wait ScreenAudio key or system timeout and not docked: Start Screen - INS ChargeStatus Not Docked Screen Audio key or system timeout and docked: StartScreen - INS Charge Status - Docked 90 to 100% Therapy On/Off andtelemetry success and not docked: Start Screen - Not Docked with TherapyOn/Off icon on status line (Table 17-22) Therapy On/Off and telemetrysuccess and docked: Start Screen - Docked with Therapy On/Off icon onstatus line (Table 17-22) Therapy On/Off and telemetry event: Refer toTable 18 Start Charge and antenna temperature OK: Wait Screen (Table17-1) Start Charge and antenna too hot: INS Charge Status - Antenna TooHot Screen (Table 17-13) Stop Charge: no change Attach/detach DTC: nochange Physician Recharge Audio key or system timeout and not docked:Start Screen - Screen Not Docked Physician Recharge Audio key or systemtimeout and docked: Start Screen - Screen - Antenna Docked Too HotTherapy On/Off: no change Start Charge: no change Stop Charge: no changeAttach/detach DTC: no change Screen Entry: User Control/System EventTherapy On/Off Start Charge User Control/System Event: Next Screen(assuming antenna Entry Screen and recharger are making full contact)All screens and Audio key or system timeout and not docked: StartScreen - messages with the Not Docked exception of Audio key or systemtimeout and docked: Start Screen - Physician Recharge Docked Screen,Physician Therapy On/Off and telemetry success and not docked: StartRecharge - Screen - Not Docked with Therapy On/Off icon on status lineAntenna Too Hot (Table 17-22) Screen, IR Therapy On/Off and telemetrysuccess and docked: Start Communication Screen - Docked with TherapyOn/Off icon on status line Screen, Splash (Table 17-22) Screen and allTherapy On/Off and telemetry event: Refer to Table 18 reposition antennaStart Charge and antenna temperature OK: Wait Screen (Table warnings17-1) Start Charge and antenna too hot: Antenna Too Hot Message (Table17-30) Stop Charge: no change Attach/detach DTC: no change 22-INS ChargeStatus - 90 to 100% Screen Screen Entry: User Control/System EventSystem timeout or message clear Antenna temperature OK Battery voltageindicates 90% User Control/ System Event System Response: Feedback/NextScreen (requirement) Therapy On/Off Telemetry success: Therapy On/Officon on status line (Table 17-22) Telemetry event: refer to Table 18Start Charge Start Charge and antenna temperature OK: Wait Screen (Table17-1) Start Charge and antenna too hot: INS Charge Status - Antenna TooHot Screen (Table 17-13) Stop Charge INS Recharge Complete Message(Table 17-6) Audio Toggle Audio icon (Table 17-24) Attach DTC Powersource symbol on status line (Table 17-23) Detach DTC INSR battery low:INSR Battery Low Message (Table 17-8) INSR battery depleted: RechargeINSR Warning (Table 17-9) Status line without power source symbol (Table17-23) INS recharge complete INS Recharge Complete Message (Table 17-6)INS error: ERI Call Your Doctor ERI Message (Table 17-19) User Control/System Event System Response: Feedback/Next Screen (requirement) INSerror: POR Call Your Doctor - POR Message (Table 17-27) INS error: EOS,battery Call Your Doctor Warning (Table 17-18) voltage too high Antennatoo hot INS Charge Status - Antenna Too Hot (Table 17-13) Antennafailure Call Your Doctor Warning (Table 17-18) Antenna disconnectedConnect INSR Antenna Message (Table 17-14) INSR battery low INSR BatteryLow Message (Table 17-8) INSR battery depleted Recharge INSR Warning(Table 17-9) INSR recharge INSR Batt1 on status line (Table 17-25)complete System error Call Your Doctor Warning (Table 17-18) Audio +Stop Charge No change Audio + Start Charge No change and hold for >10seconds 23-INS Charge Status - Antenna Too Hot Screen Screen Entry: UserControl/System Event Antenna too hot System timeout or message clearUser Control/ System Event System Response: Feedback/Next Screen(requirement) Therapy On/Off Telemetry success: Therapy On/Off icon onstatus line (Table 17-22) Telemetry event: refer to Table 18 StartCharge Start Charge and antenna temperature OK: Wait Screen (Table 17-1)Start Charge and antenna too hot: INS Charge Status - Antenna Too HotScreen (Table 17-13) Stop Charge Not docked: Start Screen - Not DockedDocked and INSR recharge complete: INSR Recharge Complete Message (Table17-11) Docked and INSR recharge incomplete: INSR Charge Status Screen(Table 17-7) Audio Toggle Audio icon (Table 17-24) Attach DTC Powersource symbol on status line (Table 17-23) Detach DTC INSR battery low:INSR Battery Low Message (Table 17-8) INSR battery depleted: RechargeINSR Warning (Table 17-9) Status line without power source symbol (Table17-23) INS error: ERI Call Your Doctor ERI Message (Table 17-19) INSerror: POR Call Your Doctor - POR Message (Table 17-27) INS error: EOS,battery Call Your Doctor Warning (Table 17-18) voltage too high Antennatoo hot INS Charge Status - Antenna Too Hot (Table 17-13) Antenna cooledWait Screen/INS Charge Status (Table 17-1) Antenna failure Call YourDoctor Warning (Table 17-18) Antenna disconnected Connect INSR AntennaMessage (Table 17-14) INSR battery low INSR Battery Low Message (Table17-8) INSR battery depleted Recharge INSR Warning (Table 17-9) INSRrecharge INSR Batt1 on status line (Table 17-25) complete System errorCall Your Doctor Warning (Table 17-18) Audio + Stop Charge No changeAudio + Start Charge No change and hold for >10 seconds 24-PhysicianRecharge - Antenna Too Hot Screen Screen Entry: User Control/SystemEvent Antenna too hot User Control/ System Event* System Response:Feedback/Next Screen (requirement) Successful INS Charge Status Screen(Table 17-2) communication with INS Timer goes to zero and StartScreen - Not Docked without Therapy On/Off icon on system times out (notstatus line (Table 17-22) docked) Timer goes to zero and INSR rechargeincomplete: INSR Charge Status Screen system times out (Table 17-7)(docked) INSR recharge complete: INSR Recharge Complete Message (Table17-11) Stop Charge (not Start Screen - Not Docked docked) Stop Charge(docked) Start Screen - Docked Detach DTC INSR battery low: INSR BatteryLow Message (Table 17-8) INSR battery depleted: Recharge INSR Warning(Table 17-9) Antenna too hot Physician Mode - Antenna Too Hot (Table17-31) Antenna failure Call Your Doctor Warning (Table 17-18) Antennadisconnected Connect INSR Antenna Message (Table 17-14) System errorCall Your Doctor Warning (Table 17-18) INSR battery low INSR Battery LowMessage (Table 17-8) INSR battery depleted Recharge INSR Warning (Table17-9) INSR recharge No change complete*Note:all keys inactive except Stop Charge

TABLE 18  1 When the user presses start charge or the antenna hascooled, software will display the Wait Screen until successfulcommunication with the INS is established..  2 Software will display theINS Charge Status Screen as soon as successful communication with theINS is established.  3 Display INS Battery Low Message  4 DisplayRecharge Stimulator Warning  5 Display INS Recharge Interrupted Message 6 Display INS Recharge Complete Message  7 Display INSR Charge StatusScreen  8 Display INSR Battery Low Message  9 Display Recharge INSRWarning 10 Display INSR Recharge Interrupted Message 11 Display INSRRecharge Complete Message 12 Display Reposition Antenna Press StartCharge Warning 13 Display INS Charge Status - Antenna Too Hot Screen 14Display Connect INSR Antenna Message 15 Display Reposition Antenna PressTherapy On Warning 16 Display Reposition Antenna Press Therapy OffWarning 17 Display INSR System Infomiation Message 18 Display Call YourDoctor Warning 19 Display Call Your Doctor - ERI Message 20 Entryintentionally left blank to preserve numbering 21 Display PhysicianRecharge Screen 22 Software will display an indicator for stimulationstatus (On/Off) on the status line. 23 Software will display the powersource symbol when the desktop charger is docked. 24 Software willdisplay an indicator for audio control on the status line. 25 Softwarewill display the INSR charge level on the status line. 26 Software willupdate the recharge efficiency line each time user presses Start Charge27 Display Call Your Doctor - POR Message 28 Display IR CommunicationScreen 29 Display Splash Screen 30 Display Antenna Too Hot Message 31Display Physician Recharge - Antenna Too Hot Screen

TABLE 19 Therapy On/Off Events System Event Next Screen (requirement) 1. Telemetry failure Reposition Antenna - Press Therapy On for TherapyOn Warning (Table 17-15)  2 Telemetry failure Reposition Antenna - PressTherapy Off for Therapy Off Warning (Table 17-16)  3. INS battery lowINS Battery Low Message (Table 17-3)  4. INS battery depleted RechargeStimulator Warning (Table 17-4) or in sleep mode  5. INS error - ERICall Your Doctor - ERI Message (Table 17-19)  6. INS error - POR CallYour Doctor - POR Message (Table 17-27)  7 INS error - EOS or Call YourDoctor Warning (Table 17-18) battery voltage too high  8. INSR batterylow INSR Battery Low Message (Table 17-8)  9. INSR battery depletedRecharge INSR Warning (Table 17-9) 10. Antenna failure Call Your DoctorWarning (Table 17-18) 11. Antenna disconnected Connect INSR AntennaMessage (Table 17-14) 12. System error Call Your Doctor Warning (Table17-18) 13. Antenna too hot Display INS Charge Status - Antenna Too HotScreen (Table 17-13) or Antenna Too Hot Message (Table 17-30)

User familiarity with both external programming unit 2 and charging unit50 is enhanced through the use of common patient controls and/or displayicons across both devices. The user is presented with common controlsand displays across both platforms.

The primary purpose of external programming unit 2 is to manipulatetherapeutic programs such as starting therapy and stopping therapy. Theprimary purpose of charging unit 50 is to charge or rechargerechargeable power source 24. However, patients may want to controltheir therapy while charging unit 50 is charging the rechargeable powersource 24 of implantable medical device 16. Thus, charging unit 50 isalso equipped with controls to start and stop therapy as well ascontrols to start and stop charging.

External programming unit 2 and charging unit 50 both have similar“Therapy On” controls as illustrated in Table 1 and Table 11,respectively. Similarly, both external programming unit 2 and chargingunit 50 also have similar “Therapy Off” controls as illustrated in Table1 and Table 11, respectively.

To aid in familiarity by the user, both external programming unit 2 andcharging unit 50 also have similar or identical icons to display thesame or similar messages to the user. Battery charging level icons “INSRBatt 1”, “INSR Batt 2”, “INSR Batt 3”, “INSR Batt 4” and “INSR Batt 5”icons are similar or identical between external programming unit 2 andcharging unit 50 as illustrated in Table 1 and Table 11, respectively.

Similarly, the “Call Doctor” icon illustrated in Table 5 with respect toexternal programming unit 2 is the same as, or very nearly the same as,the “Call Doctor” icon illustrated in Table 15 with respect to chargingunit 50.

The “Warnings” icon illustrated in Table 5 with respect to externalprogramming unit 2 is the same as, or very nearly the same as, the“Warnings” icon illustrated in Table 16 with respect to charging unit50.

“Audio On” and “Audio Off” icons illustrated in Table 6 with respect toexternal programming unit 2 are the same as, or very nearly the same as,the “Audio On” and “Audio Off” icons illustrated in Table 11 withrespect to charging unit 50.

These are examples of controls and icons that are the same, or verysimilar, between both platforms, the external programming unit 2 and thecharging unit 50 to aid in user familiarity.

As noted with respect to FIG. 17 describing the process of chargingrechargeable power source 24 using external charging device 48, chargingunit 50 receives information via telemetry from implantable medicaldevice 16 during the charging process. External antenna 52 contains bothprimary coil 54 and external telemetry coil 46 and implantable medicaldevice 16 contains both secondary coil 34 and internal telemetry coil44. When external antenna 52 is positioned properly at or near the siteof implantable medical device 16, primary coil 54 can be inductivelycoupled to secondary coil 34 to facilitate the charging process.Similarly, external telemetry coil 46 can be coupled with internaltelemetry coil 44 to communicate information across cutaneous boundary38 during the charging process.

Also as noted above, magnetic shield 36 prevent electromagneticradiation stimulating secondary coil 34 from reaching the interior ofhousing 32 of implantable medical device. However, external telemetrycoil 46 and internal telemetry coil 44 are sized to be larger thanmagnetic shield 36 allowing electromagnetic communication betweenexternal telemetry coil 46 and internal telemetry coil 44.

At step 112 of the charging process illustrated in FIG. 17, a check ismade to determine if telemetry between charging unit 50 and implantablemedical device 16. Further, the status of charging rechargeable powersource 24 is communicated from implantable medical device 16 anddisplayed by charging unit 50 (step 118). The charging status displayedby charging unit 50 can be the actual known charging status ofrechargeable power source 24 as communicated from implantable medicaldevice 16 to charging unit 50. This prevents essentially guessing theinternal charging status of rechargeable power source 24 by someexternal means such as simply by the passage of time. Rather, the actualcharging status of rechargeable power source 24, e.g., the batteryvoltage, can be measured and transmitted to charging unit 50 for displayto the user.

Typically, inductive charging and telemetry operations are time divisionmultiplexed during the charging operation. That is, a portion of thetime during which charging occurs is dedicated to telemetry. During thisdedicated telemetry time, the inductive charging by primary coil 54 tosecondary coil 34 is momentarily stopped and telemetry allowed to occur.As soon as telemetry has occurred and the required information has beencommunicated, inductive coupling can be resumed. Typically, only arelatively small portion of the time period during charging is requiredto be devoted to telemetry. Inductive charging can be stopped only for ashort, e.g., a few seconds, to allow for telemetry and then inductivecharging can be resumed. Although the time division multiplexing occursover the entire charging period, only a small portion of the chargingtime is lost to telemetry. Time division multiplexing of inductivecoupling charging and telemetry prevents the possibility of inductivecharging from interfering with telemetry signals.

Thus, embodiments of the user interface for external charger forimplantable medical device are disclosed. One skilled in the art willappreciate that the present invention can be practiced with embodimentsother than those disclosed. The disclosed embodiments are presented forpurposes of illustration and not limitation, and the present inventionis limited only by the claims that follow.

1. An implantable medical device system, comprising: an implantablemedical device for providing a therapeutic output to a patient; anexternal patient control unit which can be operatively coupled viatelemetry with said implantable medical device allowing said patient tocontrol said therapeutic output of said implantable medical device; andan external energy transfer unit which can be operatively coupled tosaid implantable medical device to transcutaneously transfer energy tosaid implantable medical device; said external patient control unithaving a user interface operable by said patient having patient controlsand display icons indicative of a status of operation of said patientcontrol unit; said energy transfer unit having a user interface operableby said patient having patient controls and display icons indicative ofa status of operation of said energy transfer unit; at least some ofsaid patient controls and said display icons of said energy transferunit being common with at least some of said patient controls and saiddisplay icons of said patient control unit.
 2. A system as in claim 1wherein at least one of said display icons comprises an iconrepresentative of a state of charging of an energy storage device insaid implantable medical device.
 3. A system as in claim 1 wherein atleast one of said patient controls comprises a control for adjustingsaid therapeutic output of said implantable medical device.
 4. A systemas in claim 1 wherein said external energy transfer unit inductivelycouples energy to said implantable medical device.
 5. A system as inclaim 1 wherein said implantable medical device has a rechargeableenergy storage device and wherein said energy transfer unit charges saidrechargeable energy storage device.
 6. An external energy transfer unitadapted to transcutaneously transfer energy to an implantable medicaldevice for providing a therapeutic output to a patient, said implantablemedical device capable of communication with an external patient controlunit allowing said patient to control said therapeutic output of saidimplantable medical device, said external patient control unit having auser interface operable by said patient having patient controls anddisplay icons indicative of a status of operation of said patientcontrol unit, comprising: a user interface operable by said patienthaving patient controls and display icons indicative of a status ofoperation of said energy transfer unit; at least some of said patientcontrols and said display icons of said energy transfer unit beingcommon with at least some of said patient controls and said displayicons of said patient control unit.
 7. An external energy transfer unitas in claim 6 wherein at least one of said display icons comprises anicon representative of a state of charging of an energy storage devicein said implantable medical device.
 8. An external energy transfer unitas in claim 6 wherein at least one of said patient controls comprises acontrol for adjusting said therapeutic output of said implantablemedical device.
 9. An external energy transfer unit as in claim 6wherein said external energy transfer unit inductively couples energy tosaid implantable medical device.
 10. An external energy transfer unit asin claim 6 wherein said implantable medical device has a rechargeableenergy storage device and wherein said energy transfer unit charges saidrechargeable energy storage device.
 11. A method of providingtherapeutic output to a patient using an implantable medical device,comprising the steps of: operatively coupling via telemetry an externalpatient control unit with said implantable medical device allowing saidpatient to control said therapeutic output of said implantable medicaldevice; and operatively coupling an external energy transfer unit tosaid implantable medical device to transcutaneously transfer energy tosaid implantable medical device; said external patient control unithaving a user interface operable by said patient having patient controlsand display icons indicative of a status of operation of said patientcontrol unit; said energy transfer unit having a user interface operableby said patient having patient controls and display icons indicative ofa status of operation of said energy transfer unit; at least some ofsaid patient controls and said display icons of said energy transferunit being common with at least some of said patient controls and saiddisplay icons of said patient control unit.
 12. A method as in claim 11wherein at least one of said displays icons comprises an iconrepresentative of a state of charging of an energy storage device insaid implantable medical device.
 13. A method as in claim 11 wherein atleast one of said patient controls comprises a control for adjustingsaid therapeutic output of said implantable medical device.
 14. A methodas in claim 11 wherein said external energy transfer unit inductivelycouples energy to said implantable medical device.
 15. A method as inclaim 11 wherein said implantable medical device has a rechargeableenergy storage device and wherein said energy transfer unit charges saidrechargeable energy storage device.
 16. An implantable medical devicesystem, comprising: an implantable medical device for providing atherapeutic output to a patient; and an external energy transfer unitwhich can be operatively coupled to transcutaneously transfer energy tosaid implantable medical device; said energy transfer unit beingoperable by said patient with less than three operative controls tocontrol energy transfer from said external energy transfer unit to saidimplantable medical device.
 17. A system as in claim 16 wherein saidenergy transfer unit is operable with two operative controls to controlenergy transfer from said external energy transfer unit to saidimplantable medical device.
 18. A system as in claim 17 wherein said twooperative controls comprise a start control and a stop control.
 19. Asystem as in claim 18 wherein said start control is a start button andwherein said stop control is a stop button.
 20. A system as in claim 16wherein said energy transfer unit further comprises operative controlsto start and stop said therapeutic output of said implantable medicaldevice.
 21. A system as in claim 16 wherein said energy transfer unitfurther comprises a control to enable and silence audio feedback fromsaid energy transfer unit.
 22. A system as in claim 16 wherein saidexternal energy transfer unit inductively couples energy to saidimplantable medical device.
 23. A system as in claim 16 wherein saidimplantable medical device has a rechargeable energy storage device andwherein said energy transfer unit charges said rechargeable energystorage device.
 24. An external energy transfer unit adapted totranscutaneously transfer energy to an implantable medical device forproviding a therapeutic output to a patient, comprising: energy transfercircuitry to transcutaneously transfer energy to said implantablemedical device; and less than three operative controls to control energytransfer from said external energy transfer unit to said implantablemedical device.
 25. An external energy transfer unit as in claim 24wherein said less than three operative controls comprises two operativecontrols to control energy transfer from said external energy transferunit to said implantable medical device.
 26. An external energy transferunit as in claim 25 wherein said two operative controls comprise a startcontrol and a stop control.
 27. An external energy transfer unit as inclaim 26 wherein said start control is a start button and wherein saidstop control is a stop button.
 28. An external energy transfer unit asin claim 24 wherein said energy transfer unit further comprisesoperative controls to start and stop said therapeutic output of saidimplantable medical device.
 29. An external energy transfer unit as inclaim 24 wherein said energy transfer unit further comprises a controlto enable and silence audio feedback from said energy transfer unit. 30.An external energy transfer unit as in claim 24 wherein said externalenergy transfer unit inductively couples energy to said implantablemedical device.
 31. An external energy transfer unit as in claim 24wherein said implantable medical device has a rechargeable energystorage device and wherein said energy transfer unit charges saidrechargeable energy storage device.
 32. A method for providing atherapeutic output to a patient with an implantable medical device,comprising the steps of: operatively coupling an external energytransfer unit with said implantable medical device to transcutaneouslytransfer energy to said implantable medical device; and controlling saidenergy transfer unit with less than three operative controls to controlenergy transfer from said external energy transfer unit to saidimplantable medical device.
 33. A method as in claim 32 wherein saidcontrolling step is accomplished with two operative controls.
 34. Amethod as in claim 33 wherein said two operative controls comprise astart control and a stop control.
 35. A method as in claim 34 whereinsaid start control is a start button and wherein said stop control is astop button.
 36. A method as in claim 32 further comprising the step ofcontrolling said energy transfer unit to start and stop said therapeuticoutput of said implantable medical device.
 37. A method as in claim 32further comprising the step of controlling said energy transfer unit toenable and silence audio feedback from said energy transfer unit.
 38. Amethod as in claim 32 further comprising the step of inductivelycoupling energy to said implantable medical device.
 39. A method as inclaim 32 wherein said implantable medical device has a rechargeableenergy storage device and wherein said energy transfer unit charges saidrechargeable energy storage device.
 40. An implantable medical devicesystem, comprising: an implantable medical device for providing atherapeutic output to a patient, said implantable medical device capableof receiving inductively coupled energy with a secondary coil and beingcapable of being transcutaneously controlled using an internal telemetrycoil; and an external antenna having a primary coil adapted toinductively transfer energy to said secondary coil of said implantablemedical device when said external antenna is externally placed inproximity of said secondary coil; an external energy transfer unitadapted to be operatively coupled by a cord to said external antennadriving said primary coil to inductively transfer energy to saidimplantable medical device; said energy transfer unit having an externaltelemetry coil allowing said energy transfer unit to communicate withsaid implantable medical device through said internal telemetry coil inorder to at least partially control said therapeutic output of saidimplantable medical device.
 41. A system as in claim 40 wherein saidenergy transfer unit can control said implantable medical device to turnsaid therapeutic output on and off.
 42. A system as in claim 40 whereinsaid energy transfer unit can control said implantable medical deviceusing said external telemetry coil while transferring energy to saidimplantable medical using said primary coil of said antenna.
 43. Asystem as in claim 40 wherein said implantable medical device has arechargeable energy storage device and wherein said energy transfer unitcharges said rechargeable energy storage device.
 44. An external energytransfer system adapted to transcutaneously transfer energy to animplantable medical device for providing a therapeutic output to apatient, said implantable medical device capable of receivinginductively coupled energy with a secondary coil and being capable ofbeing transcutaneously controlled using an internal telemetry coil,comprising: an external antenna having a primary coil adapted toinductively transfer energy to said secondary coil of said implantablemedical device when said external antenna is externally placed inproximity of said secondary coil; and an external energy transfer unitadapted to be operatively coupled by a cord to said external antennadriving said primary coil to inductively transfer energy to saidimplantable medical device; said energy transfer unit having an externaltelemetry coil allowing said energy transfer unit to communicate withsaid implantable medical device through said internal telemetry coil inorder to at least partially control said therapeutic output of saidimplantable medical device.
 45. An external energy transfer system as inclaim 44 wherein said energy transfer unit can control said implantablemedical device to turn said therapeutic output on and off.
 46. Anexternal energy transfer system as in claim 44 wherein said energytransfer unit can control said implantable medical device using saidexternal telemetry coil while transferring energy to said implantablemedical using said primary coil of said antenna.
 47. An external energytransfer system as in claim 44 wherein said implantable medical devicehas a rechargeable energy storage device and wherein said energytransfer unit charges said rechargeable energy storage device.
 48. Amethod of controlling an implantable medical device for providing atherapeutic output, said implantable medical device capable of receivinginductively coupled energy with a secondary coil and being capable ofbeing transcutaneously controlled using an internal telemetry coil,comprising the steps of: inductively transferring energy to saidsecondary coil with an external antenna having a primary coil when saidexternal antenna is externally placed in proximity of said secondarycoil; driving said primary coil with an external energy transfer unitoperatively coupled by a cord to said external antenna to inductivelytransfer energy to said implantable medical device; and communicatingwith an external telemetry coil in said energy transfer unit with saidimplantable medical device through said internal telemetry coil in orderto at least partially control said therapeutic output of saidimplantable medical device.
 49. A method as in claim 48 wherein saidcommunicating step is operable to turn said therapeutic output on andoff.
 50. A method as in claim 48 wherein said inductively transferringstep and said communicating step occur simultaneously.
 51. A method asin claim 48 wherein said implantable medical device has a rechargeableenergy storage device and wherein said energy transfer unit charges saidrechargeable energy storage device.